Commentary: Practicing on the Tip of an Information Iceberg? Evidence of Underpublication of Registered Clinical Trials in Oncology

Ramsey, Scott D.; Scoggins, John F.

doi:10.1634/theoncologist.2008-0133

Cited by 79 publications

(47 citation statements)

References 17 publications

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“…Ramsey and Scoggins identified 2028 completed or terminated cancer trials from NIH's ClinicalTrials.gov registry in September 2007. 391 They then searched ClinicalTrials.gov and PubMed for peer-reviewed publications of these trials. It was found that only 19.5% of the 1791 completed cancer trials and 3.4% of the 237 terminated trials had been published in peer-reviewed journals.…”

Section: Prospective Registration Of Trialsmentioning

confidence: 99%

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

805

682

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address. Paying by credit cardYou can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume. How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of project...

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Section: Prospective Registration Of Trialsmentioning

confidence: 99%

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

805

682

View full text Add to dashboard Cite

show abstract

“…It is increasingly difficult for medical oncologists to keep current with the generally incremental advances published regularly by well-known and well-respected medical journals. And yet, as Ramsey and Scoggins point out in this edition of The Oncologist, we may be struggling to keep up with information that represents only "the tip of the iceberg" [3]. Slipping beneath the surface is a wealth of unpublished data that might prove valuable to the cancer research community.…”

mentioning

confidence: 99%

“…Ramsey and Scoggins hypothesize that a major reason for failure to publish is selection bias against trials that do not meet their endpoints and, indeed, the majority (57%-90%) of the published trials are positive [3]. But other factors aside from a negative result may defeat a trial and its publication.…”

mentioning

confidence: 99%

One in Five Cancer Clinical Trials Is Published: A Terrible Symptom—What's the Diagnosis?

Curt¹,

Chabner²

2008

The Oncologist

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“…6 In that regard, Ramsey and Scoggins point out that journal reviewers may be disinterested in nonsignificant trial results that do not appear to change practice or produce new information. 14 Still, recent evidence suggests several troubling deficiencies in the information that is available to physicians making prescribing Processes that encourage transparent interplay between payers, manufacturers, providers and patients may also provide part of the solution. The DoD formulary review process, described in an article elsewhere in this issue, combines detailed and evidencebased economic and clinical review with qualitative assessments of provider and beneficiary opinion.…”

Section: Interpretations Of Current Evidence About Clinical Trial Mismentioning

confidence: 99%

“…When the sample was restricted to trials registered prior to September 2004, 21.0% of trials were published after more than 3 years of follow-up. 14 A fascinating look at the process that reportedly underlies selective publication was provided in a January 2009 report by Landefeld and Steinman, who were unpaid consultants for the plaintiff (biologist David Franklin) in a lawsuit over the manufacturer's promotional activities for the anticonvulsant gabapentin. 15 Based on a content analysis of corporate documents, which became publicly available as a result of the discovery process in the litigation, study authors reported extensive evidence of ghostwriting and a "publication strategy" for marketing purposes.…”

mentioning

confidence: 99%

What Should Be Done About Bias and Misconduct in Clinical Trials?

Fairman¹,

Curtiss²

2009

JMCP

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• A 2007 analysis of promotional detailing visits for gabapentin from 1995-1999 found that 46% led to physician intention to prescribe or recommend the drug, and 38% of those visits involved discussions in which the "main message" was at least 1 off-label use. Various components of the health care system, including government regulators, journal editors, and pharmaceutical manufacturers, are cobbling together a patchwork of solutions to the problem of inaccurate "evidence" about the efficacy and safety of prescription drugs. But will their efforts be sufficient to encourage Turner et al. found a strong association between favorability of results for the study drug and likelihood of publication. Overall, of 74 FDA-registered studies conducted in 12,564 patients, 51 (68.9%) were published, including 37 of 38 studies (97.4%) that the FDA had judged as indicating positive findings for the study drug. In contrast, of 36 studies judged by the FDA to have produced negative (n = 24) or questionable (n = 12) results, 3 (8.3%) were published with the negative findings presented, 11 (30.6%) were published with a representation that the findings were positive, and 22 (61.1%) were not published. The researchers concluded that "the efficacy of [the antidepressant] drug class is less than would be gleaned from an examination of the published literature alone . . . . As a result of selective reporting, the published literature conveyed an effect size nearly one third larger than the effect size derived from the FDA data," leading physicians to make "inappropriate prescribing decisions."6 Whittington et al., studying trials of the use of selective serotonin reuptake inhibitors in children and adolescents with depression, had produced similar findings in 2004, concluding that when the unpublished data were considered, "risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people . . . . Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment." In an analysis that examined the reporting of clinical trial data used in new drug applications submitted to the FDA, Lee et al. (September 2008) identified 909 trials supporting 90 new drugs approved between 1998 and 2000, using FDA review documents and the approved drug label. The authors categorized trials as "pivotal" if they were described in both the summary document for drug approval and the "clinical studies" section of the E D I T O R I A L

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Commentary: Practicing on the Tip of an Information Iceberg? Evidence of Underpublication of Registered Clinical Trials in Oncology

Cited by 79 publications

References 17 publications

Dissemination and publication of research findings: an updated review of related biases

Dissemination and publication of research findings: an updated review of related biases

One in Five Cancer Clinical Trials Is Published: A Terrible Symptom—What's the Diagnosis?

What Should Be Done About Bias and Misconduct in Clinical Trials?

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